A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To generate initial information on the pharmacokinetics (blood levels) and dose proportionality of nevirapine (BI-RG-587) plasma levels in HIV-infected children; to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children; and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children.

Test tube studies have shown that nevirapine (BI-RG-587) inhibits replication (reproduction) of HIV. Nevirapine works with zidovudine (AZT) and is active against strains of the virus that are resistant to AZT. Studies of the drug in HIV-infected adults showed no serious adverse effects.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Boehringer Ingelheim
• Treatments: Nevirapine

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Intravenous gammaglobulin. Pneumocystis prophylaxis according to published guidelines.

Patients must have the following:

• HIV infection.

• Parent or guardian must be available to give written informed consent.

Exclusion Criteria

Concurrent Medication:

Excluded:

• Zidovudine (AZT).

• Steroid dependency.

Excluded within 1 hour before and 4 hours after study drug administration:

• Drugs that might interfere with the absorption of study drug (H2 blockers, antacids, carafate, cholestyramine).

• Benzodiazepines.

• Alcohol-containing substances.

Concurrent Treatment:

Excluded:

• Requiring supplemental oxygen.

Patients with the following are excluded:

• Active opportunistic or serious bacterial infection.

• Lymphoid interstitial pneumonitis (LIP) and steroid dependent or requiring supplemental oxygen or have a pretreatment pa02 < 70 mm Hg.

• Pre-existing malignancies.

Prior Medication:

Excluded:

• Zidovudine (AZT) within 7 days prior to administration of study drug.

Excluded for at least 4 weeks prior to drug administration:

• Other approved or investigational antiretroviral agents. All other investigational agents. Biologic response modifiers (e.g., interferon) or immunomodulators. Immunosuppressive agents (including glucocorticoids). Coumadin and other anticoagulant medications.

Prior Treatment:

Excluded:

• Red blood cell transfusion within 4 weeks of study entry.

Patients may not have the following:

• Opportunistic or serious bacterial infection.

Zidovudine (AZT) > 7 days prior to administration of study drug.

Active alcohol or drug abuse.